Actively Recruiting

Age: 0 - 18Years
All Genders
ID07375602

Multimodal Clinical Data Integration and Artificial Intelligence Modeling for Predicting Complications Following Pediatric Transcatheter Closure of Perimembranous Ventricular Septal Defect

Led by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-04-09

5249

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are developing and validating an artificial intelligence (AI) model to predict treatment-related complications in children with perimembranous ventricular septal defect (pmVSD) who have undergone transcatheter device closure. This observational study aims to determine if combining information from demographics, lab results, health records, echocardiography, chest X-rays, and electrocardiograms can accurately assess individual risk of complications within 30 days after the procedure. The study uses retrospective clinical data from pediatric patients treated at a single center. The AI model will be trained using deep learning techniques to analyze various types of clinical data, including text and images, collected from routine care records. The study does not involve any new treatments or interventions but focuses on data integration and AI prediction methods. The primary outcome is the occurrence of procedure-related complications within 30 days after the transcatheter closure. Participants are children aged 18 years or younger who had a confirmed diagnosis of pmVSD and underwent transcatheter device closure at the study center. Researchers will review medical records to gather necessary clinical and imaging data. The study evaluates the AI model's performance in predicting complications using metrics such as precision-recall curves, sensitivity, and predictive values, all within 30 days after the procedure. The study is sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, and is planned to end in June 2026.

CONDITIONS

Brief Title

A Multimodal AI Prediction Model for Complications After Transcatheter Closure of Perimembranous VSD in Children

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 64 18 years at the time of transcatheter procedure.
  • Diagnosis of perimembranous ventricular septal defect confirmed by echocardiography.
  • Underwent transcatheter device closure for pmVSD at the study center.
  • Medical records must be sufficient to determine primary outcome within follow-up window and include minimum baseline clinical information needed for AI model development and validation.
Not Eligible

You will not qualify if you...

  • Ventricular septal defects not classified as perimembranous, including muscular, outlet, or inlet VSDs, or multiple complex VSDs.
  • Presence of complex congenital heart disease or structural abnormalities needing surgical repair, such as tetralogy of Fallot.
  • Prior surgical repair or transcatheter closure of VSD.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to the day of transcatheter closure

Participants undergo evaluation to confirm diagnosis of perimembranous ventricular septal defect and eligibility for the study.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 30 days after transcatheter closure

Participants are observed and data collected to monitor for procedure-related complications and outcomes after transcatheter closure of perimembranous VSD.

Approximately 2 to 3 visits (in-person or remote) within 30 days post-procedure

Trial Site Locations

Total: 1 location

1

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200092

Actively Recruiting

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Research Team

K

Kun Sun

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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